Labeler
AMICUS THERAPEUTICS US, LLC NDC Codes
AMICUS THERAPEUTICS US, LLC lists 3 finished drug products in the FDA NDC Directory under NDC labeler code 71904.
Overview
Each product below links to its own NDC page with package NDCs in 10- and 11-digit form.
- Drugs
- Pombiliti Atga, Opfolda, Galafold
- Active ingredients
- Cipaglucosidase alfa, Miglustat, Migalastat hydrochloride
- NDC labeler codes
- 71904
- Strengths
- Cipaglucosidase alfa 105 mg/1; Miglustat 65 mg/1; Migalastat hydrochloride 123 mg/1
- Dosage forms
- Capsule, Injection, Powder, Lyophilized, For solution
- Routes
- Oral, Intravenous
- Drug classes (FDA established)
- Hydrolytic Lysosomal Glycogen-specific Enzyme, Enzyme Stabilizer, Glucosylceramide Synthase Inhibitor
- HCPCS / J-code
- None in Med-Code's directory for these products
- Package NDCs
- 7
NDC codes
Newest listings first. Each row links to the product’s NDC page.
| Product | Strength | Form · route | Product NDC | Package NDCs (11-digit) | HCPCS |
|---|---|---|---|---|---|
| Pombiliti Atgacipaglucosidase alfa-atga | Cipaglucosidase alfa 105 mg/1 | Injection, Powder, Lyophilized, For solutionIntravenous | 71904-200 | 71904-0200-0171904-0200-0271904-0200-03 | — |
| Opfoldamiglustat | Miglustat 65 mg/1 | CapsuleOral | 71904-300 | 71904-0300-0171904-0300-0271904-0300-03 | — |
| Galafoldmigalastat hydrochloride | Migalastat hydrochloride 123 mg/1 | CapsuleOral | 71904-100 | 71904-0100-01 | — |
AMICUS THERAPEUTICS US, LLC: common questions
- What is AMICUS THERAPEUTICS US, LLC's NDC labeler code?
- 71904. The labeler code is the first segment of each NDC. About labeler codes.
- Is there a J-code for AMICUS THERAPEUTICS US, LLC?
- Med-Code's curated HCPCS directory has no drug-specific code for these products. Drugs dispensed by a pharmacy are billed by NDC. NDC vs J-code.
- Which NDC goes on a claim?
- The package NDC of what was given, in 11-digit form. How to convert a 10-digit NDC.